Module 1 2021

01/07/2021

Long time between MAA date for adults and agreed PIP completion date-MAA for children

• Many in the early days of the paediatric regulation long deferrals were agreed • Start early with the paedicatric studies!

The Organisation for Professionals in Regulatory Affairs

31

The development of paediatric medicines for children are not equally divided over all paediatric areas

• Few products for paediatric only diseases • Many products for diseases with high unmet medical need but few paediatric patients

The Organisation for Professionals in Regulatory Affairs

32

16